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Project Manager IV
Ref No.: 18-02710
Location: Bridgewater, New Jersey
Position Type:Contract
Start Date / End Date: 05/28/2018 to 12/31/2018
TItle: Project Manager
Location: Bridgewater, NJ
Duration: 5 Months Contract

  • Candidate will provide Regulatory Advertising and Promotion coverage for the MS and Rare Disease franchises and training.
  • This will involve review of all promotional and disease related materials, weekly meetings with PRB teams for each product, and completion of required Clients forms for the approval of the marketing piece.
  • Regulatory expertise in support of commercial communications strategy and implementation of advertising and promotional materials for the US market for Rare Diseases and MS products in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy.
  • Sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions assigned products, and is consistent with applicable FDA regulations and policies.
Other Duties:
  • Reviewing advertising and promotional materials and marketing activities on a weekly basis
  • Providing comments and regulatory advice on each material
  • attending Review Committee weekly meetings to discuss the materials across the review team
  • Conducting a verification step to ensure final materials are released for Marketing use.
  • Providing comments and regulatory advice on each material
  • Knowledge of FDA monitoring and competitor activity
  • Regulatory support for maintenance activities for marketed products
  • Preparation of safety reports, NDA annual reports